University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Location status: Recruiting
NCT Number: NCT06587230
Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted child mental health care.
Participants: ~300 estimated
Procedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods, clustered evaluation of Tealeaf-NC's Reach, Adoption & Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness & Maintenance (Secondary Outcomes, clinically-based).
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Request Info5 year–99 year
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27514, United States
Location status: Recruiting
Addressing children's mental health is a critically important health challenge. Twenty percent of all children suffer from significant mental health concerns, most of whom will remain unrecognized, unsupported, and affected throughout their lives. Such wide differences between mental health needs and care access are often called the "care gap". More recently, a youth mental health crisis emerged alongside the COVID-19 pandemic. The adverse impact of the pandemic has led to youth mental health prevalence increasing up to 40% in some global regions, which is double the pre-pandemic rate, while available professional mental health human resources have not changed, leading to an even wider care gap. As urgent solutions are needed, alternative systems of care and support may address this urgent need in a more timely fashion than expanding traditional care systems would.
The overarching goal of this study is to address the youth mental health crisis by providing evidence that high-quality, alternative, sustainable child mental health care may improve youth mental health symptoms. This proposal aims to pilot a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted child mental health care. In North Carolina, USA, the investigators will pilot Teachers Leading the Frontlines - Mansik Swastha [Mental Health in Nepali] (Tealeaf). Created in Darjeeling, India, Tealeaf centers on training and supervising elementary school teachers to deliver "education as mental health therapy" (Ed-MH) to children (ages 5-12). Ed-MH is the investigators' novel, task-shifting, therapy modality that minimizes the time teachers need to deliver care by fitting it into their work. In Ed-MH, teachers use evidence-based therapeutic techniques adapted for use in their existing interactions with students in need (e.g., while teaching) and streamlined for care for any diagnosis ("transdiagnostic").
The investigators' rationale stems from two trials in Darjeeling where the mental health symptoms of children in Tealeaf improved from clinical to neurotypical. The investigators specifically aim to determine if teachers can deliver Tealeaf with fidelity, with positive acceptability & feasibility for stakeholders, and leading to preliminary indicators of improved child mental health outcomes. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) public health framework, the investigators hypothesize that a pilot of Tealeaf clustered at the school level will show that:
Researchers will compare Tealeaf with an active comparator, RE-SEED (Responding to Students' Emotions through Education), to see if a lower-resourced version of Tealeaf is viable and/or has an impact.
Tealeaf has six components implemented over a school year:
For RE-SEED (active comparator), processes are similar to Tealeaf. The differences are that training is 1-day such that they receive markedly less in-depth knowledge, and the study team does not provide supervision, allowing only the counselor to provide supervision. This less resource-intensive approach will allow for an ethical comparator to Tealeaf, where schools would like for teachers to have some skills to support identified students as part of their willingness to participate in research, while also allowing the investigators to begin to understand what impact fewer resources may have versus a full intervention.
Tealeaf and Ed-MH's mechanism of action for improving mental health symptoms is through teachers guiding children to consistently practice coping skills and emotion regulation for long periods (a school day) and in real-time (in moments of concern). Like counselors, Tealeaf teachers help students gain insight and acquire coping skills. Teachers take the therapy activities further, though, by overseeing children practicing coping skills, reinforcing positive behavior, and supporting them in moments of struggle, all in real-time. It is ideally how teachers would work with students as guided by a therapist, but here they determine how to therapeutically respond to a student's mental health needs since therapists are inaccessible. Moreover, as a role model, teachers already play a key role in the social, emotional, and academic development of students and interact with them individually in moments of concern. Ed-MH allows teachers to deliver therapy in shared moments, in real time. Professional and lay counselors, instead, can only reflect from afar on moments the student is willing to share in the office.
A second mechanism of action is through teachers delivering care that can target education symptoms of mental health as seen in India. For example, a student may have poor schoolwork due to anxiety. Their teacher can target their poor schoolwork (the education symptoms of their mental health) and anxiety by improving schoolwork quality (an education intervention) by building their capacity to complete assignments gradually, i.e. exposure therapy (an evidence-based technique). After care, both symptoms improved.
Intervention evidence: Results from 2018 and 2019 pilot Tealeaf trials show that mental health care delivery for children can be shifted to teachers.
Overall, our prior research demonstrates that teacher-delivered transdiagnostic mental health care (Tealeaf inclusive of Ed-MH) may be a potentially efficient, sustainable, and impactful approach. A Type 1 hybrid effectiveness-implementation Tealeaf trial is ongoing in Darjeeling, India.
The investigators' rationale for pilot testing Tealeaf-NC is based on Tealeaf's promising results as there is an urgent need to identify and deliver evidence-based children's mental health interventions to tackle the children's mental health care gap that worsened into a crisis during the COVID pandemic. Of note, Tealeaf skipped over efficacy (lab-like setting) to effectiveness testing (real world), as literature supports skipping efficacy testing of task-shifted mental health care. Task-shifting improves mental health outcomes in lab-like settings and is now recommended to be tested in specific forms (e.g., teacher-delivery) for specific contexts to study its effects in real-world practice. As research evidence takes an average of 17 years to reach clinical practice, and given Tealeaf's promise, the urgent need justifies pilot testing Tealeaf's potential implementation and clinical outcomes in new settings.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Schools:
Principals:
Teachers:
Counselors:
Students:
Guardians:
Exclusion criteria
Other names: Tealeaf
All processes for RE-SEED are the same as in Tealeaf except...
This less resource-intensive approach will allow for an ethical comparator to Tealeaf, where the schools would like for teachers to have some skills to support identified students.
Other names: RE-SEED
Time frame: Month 0, Month 9
The Acceptability of Intervention Measure (AIM) measures the stakeholder's beliefs about the acceptability of the assigned intervention. Each element is scored from 1 (Completely disagree) to 5 (Completely agree). Mean scores are calculated, with a higher score indicating that the teacher believes the intervention is more acceptable, and a score greater than or equal to 4 indicating positive acceptability.
Time frame: Month 0, Month 9
The Intervention Appropriateness Measure (IAM) measures the stakeholder's beliefs about the appropriateness of the assigned intervention. Each element is scored from 1 (Completely disagree) to 5 (Completely Agree). Mean scores are calculated, with a higher score indicating that the teacher believes the intervention is more appropriate, and a score greater than or equal to 4 indicating the intervention is more appropriate.
Time frame: Month 0, Month 9
The Feasibility of Intervention Measure (FIM) measured the stakeholder's beliefs about the feasibility of the assigned intervention. Each element is scored from 1 (Completely disagree) to 5 (Completely agree). Mean scores are calculated, with a higher score indicating that the teacher believes the intervention is more feasible, and a score greater than or equal to 4 indicating positive feasibility.
Time frame: Month 9
The Cause Analysis Chart (AABC) Evaluation Checklist is a study-specific tool that assists evaluators in scoring the fidelity with which teachers accurately complete the AABC Chart. Mean scores are calculated and can range from 1 (Needs improvement) to 5 (Advanced) with a higher mean score indicating higher fidelity, and an overall mean score greater than or equal to 4 indicating sufficient fidelity.
Time frame: Month 9
The 4Cs Behavior Plan Evaluation Checklist is a study-specific tool that assists evaluators in scoring the fidelity with which teachers accurately complete the 4Cs Behavior Plan. Mean scores are calculated and can range from 1 (Needs improvement) to 5 (Advanced) with a higher mean score indicating higher fidelity, and an overall mean score greater than or equal to 4 indicating sufficient fidelity.
Time frame: Month 9
The One-on-One Student Interaction Evaluation Tool is a study-specific tool that measures the fidelity with which teachers conduct one-on-one sessions with the student(s). Teachers are rated on six domains on a scale that ranges from 1 (Needs Improvement) to 5 (Advanced). Scores are averaged and rounded to a half point across domains to yield mean scores from 1 to 5 with a mean higher score indicating higher fidelity, and a mean score greater than or equal to 4 indicating sufficient fidelity.
Time frame: Month 9
The One-on-One Family Interaction Evaluation Tool is a study-specific tool that measures the fidelity with which teachers conduct family interactions. Teachers are rated on six domains on a scale that ranges from 1 (Needs improvement) to 5 (Advanced). Scores are averaged and rounded to a half point across domains to yield mean scores from 1 to 5 with a mean higher score indicating higher fidelity, and a mean score greater than or equal to 4 indicating sufficient fidelity.
Time frame: Month 0, Month 9
The Strengths and Difficulties Questionnaire is a brief behavioral screening that will measure the mental health of students, and the change in scores will measure the effectiveness of the assigned intervention. The total difficulties score is the summation of 4 subscales: emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems. Each subscale has 5 items scored as "Not True," "Somewhat True," and "Certainly True" yielding a value of 0,1, or 2. (Some items are scored in reverse). The total difficulties score is generated by summing scores from each scale to yield an overall score. The overall score range is from 0-40, with a higher score indicating more difficulties/worse mental health. A bigger decrease in the total difficulties scores will indicate that the intervention is more effective.
Time frame: Up to 18 months
Using the teachers' and school records, the number of days present will be converted to a proportion of days in attendance (due to the varied length of academic school years). These proportions will be compared between arms, and a higher proportion of attendance will indicate a more effective intervention.
Time frame: Up to 18 months
Using the teachers' and school records, a change in student academic achievement score will be coded from available grades, assessment, discipline and IEP/504 information. A significant change in the positive direction will indicate an effective intervention.
Contact information is provided by the study sponsor or research team.
Christina Cruz, MD
CONTACT
Michael Matergia, MD
CONTACT
University of North Carolina, Chapel Hill
Other
Building Teachers Mental Health Skills to Support Students With Mental Health Needs in Elementary and Middle Schools in North Carolina: Program Implementation and Prospective Data Collection
Acronym: Tealeaf-NC
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